Clinical Trial

Low Sodium Oxybate in Patients With Idiopathic Hypersomnia

Recruiting Phase 4
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Summary
Low sodium oxybate has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic hypersomnia. In this study, the researchers want to learn how low sodium oxybate impacts ability of people diagnosed with idiopathic hypersomnia to sleep for long periods of time. In addition, this study will use novel tools to determine when an individual is awake or asleep.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2023-04-19; most recent amendment 2026-05-08.
Status change: Not Yet Recruiting → Recruiting 2023-09-13
Trial Details
NCT Number NCT05837091
Lead Sponsor Mayo Clinic
Conditions Idiopathic Hypersomnia
Enrollment 30 participants
Start Date 2024-02-14
Primary Completion 2027-01-29 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-05-12